Supreme Court justices grappled Monday with arguments about the Food and Drug Administration’s regulation of flavored e-cigarettes, and whether the agency acted unfairly in its decision to bar two companies from marketing their products with flavors the agency deemed were a risk to young people.
The justices examined whether FDA acted in an “arbitrary and capricious” manner when it made the decision to deny approval to the companies selling flavors including sour grape, pink lemonade and crème brûlée, and names including “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”
FDA found that the companies, Triton and Vapetasia LLC, failed to offer reliable and robust evidence to overcome the risks of youth addiction and show a benefit to adult smokers.
But the companies sued, claiming FDA changed the rules mid-review on how the products would be evaluated. They said flavored products can be used to help adults stop smoking.
Several lower courts all ruled in favor of FDA, but the ultra-conservative U.S. Court of Appeals for the 5th Circuit said FDA had moved its goalposts. The court slammed FDA’s conduct, claiming the companies were told that the agency required certain studies but then changed its mind and required different studies.
The court did not order FDA to approve the products but told the agency to reconsider and conduct another review.
The agency appealed to the Supreme Court, arguing that if the decision from the lower court were allowed to stand, it would “seriously impair FDA’s efforts to protect young people from the harmful effects of e-cigarettes.”
Conservative justices homed in on the alleged shifting standard, but a majority of the court seemed largely unsympathetic to the argument.
Justice Clarence Thomas asked the government, represented by Justice Department Attorney Curtis Gannon, to respond to the argument that the guidance was “actually a moving target.”
Gannon said the agency’s position has been consistent.
“I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth. They knew throughout that FDA was concerned about the fact that flavors are attractive to youth,” Gannon said.
Justice Brett Kavanaugh pushed back at the vaping company attorney, joining the liberal justices in noting that FDA had been clear from the outset that it was making decisions based on whether the products appealed to young people.
If after the agency reviews the application and rejects it, “it’s kind of the end of it, isn’t it?” Kavanaugh said.
Justice Elena Kagan had a similar argument.
“FDA has been pretty upfront about this,” Kagan told the companies’ lawyer Eric Heyer.
“There’s just not a lot of mystery here about what FDA was doing. You might disagree with that. But you can’t say FDA hasn’t told you all about what it was thinking,” Kagan said.
The case comes as teen vaping rates have dropped to the lowest level in a decade, which federal officials attribute mostly to regulatory efforts.
Still, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Nearly 90 percent of them use illicit flavored brands, according to federal data.
The FDA has authorized the sale of only 27 e-cigarette products, and all except one have been tobacco flavored, which is not widely used by young people. It has denied millions of others. Companies seeking the agency’s approval must clear a high legal bar since such products pose a “known and substantial risk to youth,” the FDA said.
E-cigarette companies must show that their product would be “appropriate for the protection of the public health.”
But looming over the case is the future of FDA’s approach to vaping. President-elect Trump has vowed to “save vaping,” though his administration in 2020 attempted to restrict flavored vaping products.
The Vapor Technology Association, a trade group representing manufacturers, retailers and others, said in a statement the incoming administration “can quickly and decisively end all current litigation — and all future litigation that will follow a SCOTUS decision favorable to industry — by implementing a new tobacco products standard.”
